EP1671591B1 - Vorrichtung zum Verschliessen einer Öffnung in einem Gewebe - Google Patents

Vorrichtung zum Verschliessen einer Öffnung in einem Gewebe Download PDF

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Publication number
EP1671591B1
EP1671591B1 EP05027557A EP05027557A EP1671591B1 EP 1671591 B1 EP1671591 B1 EP 1671591B1 EP 05027557 A EP05027557 A EP 05027557A EP 05027557 A EP05027557 A EP 05027557A EP 1671591 B1 EP1671591 B1 EP 1671591B1
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EP
European Patent Office
Prior art keywords
thread
deformation
deformation portion
tissue closure
anchor
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
EP05027557A
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English (en)
French (fr)
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EP1671591A1 (de
Inventor
Masakatsu c/o Terumo Kabushiki Kaisha Kawaura
Tomoji c/o Terumo Kabushiki Kaisha Maruyama
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Terumo Corp
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Terumo Corp
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Publication date
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Publication of EP1671591A1 publication Critical patent/EP1671591A1/de
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00606—Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00619—Locking means for locking the implement in expanded state
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00623—Introducing or retrieving devices therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00646—Type of implements
    • A61B2017/00659—Type of implements located only on one side of the opening

Definitions

  • the present invention generally relates to devices used in medical treatment or a medical procedure. More particularly, the present invention pertains to a tissue closure and a tissue closing device.
  • Low-invasion operations involving inserting a device for diagnosis or therapy such as a catheter into a blood vessel or some other in vivo tissue are known.
  • a device for diagnosis or therapy such as a catheter into a blood vessel or some other in vivo tissue
  • Such insertion of a catheter into a blood vessel is normally performed through a puncture formed by dissecting the femoral region. Accordingly, after the treatment is completed, it is necessary to stanch the bleeding from the puncture.
  • the blood pressure upon bleeding (bleeding blood pressure) from the femoral artery is relatively high, a person involved in the medical treatment must continue to hold down or apply pressure to the required part for a relatively long period of time using his/her finger.
  • U.S. Patent No. 5,690,674 discloses a device for closing a hole formed in a blood vessel, wherein two flexible disk-like members are integrated so that they are connected at their central portions. This device is invariable of the positional relationship of the two disk-like members and is fixed by the flexibility of the two disk-like members in the wound hole.
  • a patient subjected to a catheter treatment and a test on the heart or the like may have blood vessel disease at a location other than the heart, and a blood vessel lesion may be present also in the femoral artery through which a catheter is inserted.
  • the blood vessel wall thickness of the femoral artery through which the catheter is inserted is about 1 mm in the case of a healthy blood vessel, but there may be cases where the blood vessel has been thickened to a wall thickness of 2 mm or more, or where the blood vessel wall has become hard through calcification.
  • the periphery of a punctured portion.of a blood vessel may have become fibrous and turned into a hard vestigium.
  • the size of a wound formed by the insertion of a catheter differs for individual patients depending on the elasticity, wall thickness, lesion or the like of the blood vessel.
  • U.S. Patent No. 5,593,422 discloses a device in which a closing member to which a thread is attached is disposed in a blood vessel and a ring (locking member) is moved along the thread. Then ring locks the thread outside the blood vessel to close up the hole formed in the blood vessel.
  • the closing member is secured to the wall of the blood vessel by fixing the ring to the thread in some way.
  • the outside diameter of the ring needs be of a dimension allowing the ring to be inserted into the wound hole, the ring must be formed in a small size, and there is the possibility that the ring may drop into the blood vessel through the hole formed in the blood vessel.
  • US Patent No 3 874 388 discloses a tissue closure device having two opposed umbrella-like elements which can be locked together in a face to face relationship.
  • a set of elevating struts hingedly attached between the regular umbrella struts and an elevating sleeve serve the purpose of erecting the umbrella under pressure of an inner catheter.
  • US Patent No 5 350 399 discloses a percutaneous arterial puncture seal device comprising: two resiliently expandable members positioned at opposite sides of the puncture opening and a thread-like member; wherein the thread-like member comprises a plurality of protrusions adapted to retain the expandable members at a variety of positions relative to each other.
  • a tissue closure for closing an opening on a wall of living body cavity comprises a plate-shaped anchor portion adapted to be held at and around the opening from one side of the wall of the living body cavity, and a deformation portion comprising a frame-shaped body.
  • the deformation portion is deformable between a first form in which the body is elongated in a direction substantially perpendicular to the anchor portion and contracted in a direction substantially parallel to the anchor portion and a second form in which the body is contracted in a direction substantially perpendicular to the anchor portion and elongated in a direction substantially parallel to the anchor portion.
  • a thread-like member comprises a knot slidable on the thread-like member, the knot being capable of maintaining the deformation portion in a desired form between the first form and the second form.
  • a tissue closure for closing an opening on a wall of living body cavity comprises an anchor portion positionable at and around the opening on one side of the wall of the living body cavity, a deformation portion deformable between a first form in which the deformation portion is elongated in a direction substantially perpendicular to the anchor portion and a second form in which the deformation portion is compressed from the first form toward the anchor portion, and a thread-like member adapted to maintain the deformation portion in a desired form between the first form and the second form.
  • the thread-like member is comprised of a double thread having one end portion thereof as a bent-back portion, and being disposed so that the deformation portion is located between the bent-back portion and the anchor portion.
  • the bent-back portion forms a loop.
  • a tissue closing device comprises a tissue closure comprising an anchor portion, a deformation portion and a thread-like member, wherein the anchor portion is positionable at and around the opening on one side of the wall of the living body cavity, the deformation portion is deformable between a first form in which the deformation portion is elongated in a direction substantially perpendicular to the anchor portion and a second form in which the deformation portion is compressed from the first form toward the anchor portion, and the thread-like member maintains the deformation portion in a desired form between the first form and the second form.
  • the tissue closure device also comprises an arrangement device possessing an elongate shape, with the arrangement device detachably retaining the tissue closure at a distal end portion thereof. The tissue closure is arranged in a living organism so as to close the opening by penetrating a tissue membrane of the wall with the tissue closure
  • a method of closing an opening on a wall of living body cavity comprising inserting a tissue closure through the opening on the wall of the living body cavity, which does not form part of the invention is also disclosed, so that an anchor portion of the tissue closure is positioned on one side of the opening, and deforming a deformation portion of the tissue closure to compress the deformation portion in a direction toward the anchor portion while the deformation portion is on an opposite side of the opening from the anchor portion, with the anchor portion being positioned to cover and close off the opening.
  • Fig. 1 is a cross-sectional view of one embodiment of the tissue closing device according to the present invention, including a tissue closure.
  • Fig. 2 is a perspective view of a tissue closure used in the tissue closing device shown in Fig. 1 .
  • Fig. 3 is an illustration of one example of a knot used in the tissue closure shown in Figs. 1 and 2 .
  • Fig. 4 is an illustration of another example of a knot used in the tissue closure shown in Figs. 1 and 2 .
  • Figs. 5(a)-5(d) are perspective views illustrating operations performed in using the tissue closing device and tissue closure shown in Figs. 1 and 2 .
  • Fig. 6 is a cross-sectional view illustrating one operational aspect of the tissue closing device shown in Fig. 1 .
  • Fig. 7 is a sectional view illustrating another operational aspect of the tissue closing device shown in Fig. 1 .
  • Fig. 8 is a sectional view illustrating another operational aspect of the tissue closing device shown in Fig. 1 .
  • Fig. 9 is a sectional view illustrating another operational aspect of the tissue closing device shown in Fig. 1 .
  • Fig. 10 is a sectional view illustrating another operational aspect of the tissue closing device shown in Fig. 1 .
  • Fig. 11 is a sectional view illustrating another operational aspect of the tissue closing device shown in Fig. 1 .
  • Fig. 12 is a sectional view illustrating another operational aspect of the tissue closing device shown in Fig. 1 .
  • Fig. 13 is a sectional view illustrating another operational aspect of the tissue closing device shown in Fig. 1 .
  • Fig. 14 is a perspective view of a second embodiment of a tissue closure used in the tissue closing device.
  • Fig. 15 is a perspective view of a third embodiment of the tissue closure used in the tissue closing device.
  • Fig. 16 is a perspective view of a fourth embodiment of a tissue closure used in the tissue closing device.
  • Figs. 17(a) to 17(d) are perspective views illustrating operational aspects of the tissue closing device using the tissue closure shown in Fig. 16 together with a pusher tube.
  • Figs. 18(a) and 18(b) are perspective views of a fifth embodiment of the tissue closure illustrating operational aspects of the tissue closing device using the tissue closure together with a pusher tube.
  • Figs. 19(a) and 19(b) are perspective views showing additional operational aspects of the tissue closing device using the tissue closure shown in Figs. 18(a) and 18(b) .
  • Fig. 20 is a perspective view of a sixth embodiment of a tissue closure used in the tissue closing device.
  • Fig. 21 is a sectional view illustrating an operational aspect of the tissue closing device using the tissue closure shown in Fig. 20 .
  • tissue closure and the tissue closing device according to the present invention will be described in detail below, based on preferred embodiments shown in the accompanying drawing figures.
  • Figs. 1 and 6-12 the left lower side in the drawings will be referred as “distal” and the right upper side will be referred to as “proximal”, and in Figs. 2-5 and 13 , the upper side in the drawings will be referred to as “proximal” and the lower side will be referred to as “distal”.
  • Fig. 1 illustrates a perspective view of a stopper 12
  • Fig. 5 schematically illustrates a pusher tube 7 in broken lines.
  • the tissue closing device 1 shown in the drawing figures and described in more detail below is a device for closing (closing up) an undesirable opening such as a wound hole formed on a living body cavity wall as an in vivo tissue membrane, for example, a living organism lumen such as a blood vessel, an internal organ of a living organism, and an internal tissue of a living organism, and is percutaneously penetrating (a wound hole penetrating an in vivo tissue lumen).
  • the tissue closing device 1 includes a clip 4, forming a tissue closure for closing an undesirable opening such as a wound hole penetrating an in vivo tissue membrane of a living body cavity wall, and a clip delivery assembly comprising an elongate body portion 2 and a thread (second thread-like member) forming a pulling means for pulling the clip 4.
  • the clip 4 is detachably mounted (retained) in a distal end portion of the body portion 2.
  • the body portion 2 includes a sheath 5 provided with a through-hole 51 passing through its central portion in the axial direction, and an elongated arrangement device 3, forming a feeding and deformation means, which is detachably mounted in the sheath 5 (e.g., is inserted in the sheath 5).
  • a stanching operation an operation or work to close a wound hole
  • distal end portions of the sheath 5 and the arrangement device 3 and the clip 4 penetrate the wound hole, respectively. Namely, they are inserted into a living body cavity (lumen of a living organism) such as a blood vessel via a wound hole.
  • the sheath 5 has a roughly hollow cylindrical shape, and is provided with a hub 52 at its proximal end portion.
  • a hemostatic valve (not shown) is disposed on the inner circumferential side of the hub 52.
  • sheath 5 examples include a sheath (introducer sheath) left indwelling after a treatment for therapy (such as Percutaneous Coronary Intervention: PCI) or diagnosis (such as Coronary AngioGraphy: CAG) using a catheter. Also, a sheath for exclusive use in the tissue closing device 1 may be used.
  • a sheath intracutaneous Coronary Intervention: PCI
  • diagnosis such as Coronary AngioGraphy: CAG
  • a sheath for exclusive use in the tissue closing device 1 may be used.
  • the components of the body portion 2 include the sheath 5 in this embodiment, the components of the body portion 2 need not necessarily include the sheath 5.
  • the arrangement device 3 includes an outer tube 6 (tubular member) which is an elongated tubular member, a pusher tube 7 (tubular member) which is an elongated tubular member adapted to be detachably mounted in or inserted into the outer tube 6, a cap 9 forming a thread-retaining member, a cap 13 forming a port-closing member for position confirmation, and a stopper 12.
  • the outer tube 6 and the pusher tube 7 constitute a major portion of the arrangement device 3 forming a feeding means for feeding the clip 4 and a deformation means for deforming a deformation portion 42 by moving a knot 461 of a thread 46 of the clip 4 (which will be described later) so as to tighten the thread 46.
  • the outer tube 6 is composed of a tube body 61 and a hub 62 provided at a proximal end portion of the tube body 61.
  • the clip 4 is detachably mounted to or retained at the distale end portion of the outer tube 6.
  • the deformation portion 42 (described later) of the clip 4 is retained in a lumen of the distal end portion of the outer tube 6, whereby the clip 4 is mounted.
  • the hub 62 has a hollow cylindrical tubular portion 621 on the distal side thereof, and a hollow cylindrical tubular portion 622 on the proximal side thereof.
  • the hub 52 of the sheath 5 is adapted to be fitted in the tubular portion 621 of the hub 62, and a tubular portion 721 of a hub 72 of the pusher tube 7 (which will be described later) is adapted to be fitted to the tubular portion 622.
  • the hub 62 is provided with an outflow port 623 forming a port for position confirmation.
  • the outflow port 623 has a through-hole which passes through the hub 62 and is communicated with the lumen of the tube body 61.
  • the cap 13 is detachably mounted to the outflow port 623.
  • the cap 13 is in the shape of a pin having a head portion, and is mounted to the outflow port 623 by being inserted into the outflow port 623, whereby the outflow port 623 is closed.
  • the tube body 61 is provided at its distal end portion with an opening 611 forming an inflow port which communicates with the lumen of the tube body 61.
  • Body fluid (blood) which has flowed through the opening 611 into the lumen of the tube body 61 can flow through a conduit defined or formed by the inside surface of the lumen of the tube body 61 and a groove (not shown) formed in the outside surface of the pusher tube 7, and to flow out via the outflow port 623.
  • the length of the outer tube 6 is set to be greater than the length of the sheath 5.
  • the distal end portion of the outer tube 6 (a portion inclusive of the opening 611) is exposed from the distal end of the sheath 5 (the distal end of the sheath 5 is located on the proximal side relative to the distal end portion of the outer tube 6).
  • the pusher tube 7 is compose of a tube body 71, and the hub 72 provided at a proximal end portion 711 of the tube body 71.
  • the purpose of the pusher tube 7 is to push the clip 4, which is mounted to the distal end portion of the outer tube 6, out of the outer tube 6 to release the clip 4.
  • the pusher tube 7 also functions to move the knot 461 of the thread 46 of the clip 4 so as to tighten the thread 46 and to thereby deform the deformation portion 42.
  • the hub 72 is provided on the distal side thereof with a hollow cylindrical tubular portion 721.
  • the thread-anchoring cap 9 forming a pulling portion fixing means is detachably mounted to the proximal end portion 711 of the tube body 71.
  • the cap 9 is in the shape of a pin having a head portion, and is mounted to the proximal end portion 711 by being inserted into a lumen of the proximal end portion 711.
  • the thread 8 With the thread 8 pulled out of the lumen of the proximal end portion 711 to the exterior and with the cap 9 mounted to the proximal end portion 711, the thread 8 is clamped between the cap 9 and the proximal end portion 711, and retained there as shown in Fig. 1 . As a result, the thread 8 is anchored to or, relative to, the proximal end portion 711 of the pusher tube 7. In addition, a spherical stopper 47 is attached to one end of the thread 8.
  • Fig. 1 also illustrates a stopper 12 that is detachably fitted to the tube body 71 of the pusher tube 7.
  • the stopper 12 is composed of a roughly C-shaped mount portion 121, and a grip portion 122. By passing the tube body 71 of the pusher tube 7 through the mount portion 121, the stopper 12 is mounted to the tube body 71 in the vicinity of the hub 72, and is disposed between the hub 72 of the pusher rod 7 and the hub 62 of the outer tube 6.
  • the clip 4 forming a tissue closure is comprised of a clip body 40 (tissue closure body), and the thread 46 forming a first thread-like member.
  • the clip body 40 is composed of an anchor portion 41, a deformable deformation portion 42, and a connecting portion 44 connecting the anchor portion 41 and the deformation portion 42 to each other.
  • the anchor portion 41, the deformation portion 42 and the connecting portion 44 i.e., the entire clip body 40
  • the anchor portion 41, the deformation portion 42 and the connecting portion 44 is preferably molded integrally in one piece of the same material.
  • the anchor portion 41 is a member having a flat surface portion (flat surface) 412 that is positioned in close contact with around a wound hole (a portion inclusive of the wound hole) from one side surface (inside surface) of the in vivo tissue membrane so as to be anchored and to cover the wound hole and the neighboring portion of the wound hole.
  • the anchor portion 41 has a plate-like shape.
  • the upper surface of the anchor portion 41 to which the deformation portion 42 is connected is in the shape of a substantially flat surface.
  • the deformation portion 42 has a pantograph-like shape (i.e., parallelogram shaped), and is linked or connected to a roughly central portion of the flat surface portion 412 of the anchor portion 41 by way of the connecting portion 44.
  • the deformation portion 42 has a frame-like shape which can be deformed between a first form in which it is elongated in a direction substantially perpendicular to the anchor portion 41 and contracted in a direction substantially parallel to the anchor portion 41 and a second form in which it is contracted in a direction substantially perpendicular to the anchor portion 41 and expanded in a direction substantially parallel to the anchor portion 41. Therefore, the deformation portion 42 can be deformed from the fundamental form or shape (initial non-deformed state) shown in Fig.
  • the one side surface is the inside surface of the blood vessel wall (living organism lumen), and the other side surface is the outside surface of the blood vessel wall (living organism lumen).
  • the deformation portion 42 has a quadrangular annular shape (a polygonal annular shape) formed by a rigid ribbon-like member having four bendable portions. Specifically, the deformation portion 42 has a quadrangular shape (quadrangular frame-like shape) having four links integrally formed in one piece and having four corner portions capable of being bent in a hinge-like manner.
  • the deformation portion 42 includes two corner portions 421, 422 at vertically opposed diagonal positions as shown in Fig. 2 .
  • the deformation portion 42 to be deformed so that the corner portion 421 and the corner portion 422 come close to and away from each other, i.e., to be deformed in a stretching and contracting manner in two orthogonal directions, and to be swung relative to the anchor portion 41.
  • the other pair of corner portions move away from each other.
  • the other pair of corner portions move closer to one another.
  • the corner portion 421 on the upper side in Fig. 2 has an upper surface (the surface on the opposite side of the anchor portion 41) formed as a curved convex surface.
  • the corner portion 421 of the deformation portion 42 (an end portion, on the opposite side of the anchor portion 41, of the deformation portion 42) is provided in the vicinity of its center with two holes 425, 428, and the corner portion 422 is provided in the vicinity of its center with two holes 426, 427.
  • the holes 425, 428, 426, 427 are through holes.
  • the connecting portion 44 has a plate-like shape and is provided with a hole 441 in the vicinity of its center.
  • the hole 441 is a through hole.
  • the thread 46 is hooked on the side of an end portion (on the opposite side of the anchor portion 41) of the deformation portion 42 and the side of an end portion (on the side of the anchor portion 41) of the deformation portion 42, and is attached to the clip body 40.
  • the thread 46 is hooked on the corner portion 421 of the deformation portion 42 (the end portion on the opposite side of the anchor portion 41 of the deformation portion 42) and the connecting portion 44 while penetrating the corner portion 421 of the deformation portion 42 and the connecting portion 44.
  • the thread 46 passes through or penetrates the hole 425 in the corner portion 421 of the deformation portion 42, the hole 426 in the corner portion 422, and the hole 441 in the connecting portion 44, sequentially from the upper side in Fig.
  • the knot 461 ties the thread 46 and can be slid on the thread 46 by applying a force (e.g., a predetermined force or more) in the distal direction.
  • the deformation portion 42 is deformed into a desired form between the first form and the second form, and this condition can be maintained by the knot 461 since the knot 461 is not slid by restoring force of the deformation portion 42. That is, once the deformation portion 42 is deformed into the desired form, the knot 461 maintains the deformation portion in the desired form and prevents the deformation portion from returning to the original non-deformed position or form.
  • the knot 461 is located at the end portion, on the opposite side of the anchor portion 41, of the deformation portion 42, i.e., at the corner portion 421.
  • the knot 461 is formed to be larger than the inside diameter of the pusher tube 7, and the loop 462 is formed to be smaller than the inside diameter of the pusher tube 7. This ensures that when the knot 461 of the thread 46 of the clip 4 is slid so as to tighten the thread 46 and thereby deform the deformation portion 42, the loop 462 can enter the lumen of the pusher tube 7, whereas the knot 461 is prevented from entering into the lumen of the pusher tube 7, and the knot 461 can be moved reliably.
  • the thread 8 in the state of being passed through the loop 462 of the thread 46 is passed through the lumen of the pusher tube 7, and both end portions of the thread 8 are led out through a proximal end portion 711 of the pusher tube 7 to the exterior.
  • the thread 8 is clamped (retained) between the cap 9 and the proximal end portion 711, and is retained at (anchored to) the proximal end portion 711.
  • the clip 4 is retained at one end portion of the thread 8 and, in this condition, the other end portion of the thread 8 is retained at (anchored to) the proximal end portion 711 of the pusher tube 7 by the cap 9.
  • the clip 4 is inhibited (prevented) from moving toward the distal side.
  • the clip 4 is also inhibited (prevented) from coming off the distal end portion of the outer tube 6.
  • the thread 8 and the thread 46 are separate threads. However, the thread 46 and the thread 8 may be in common with each other.
  • At least a part of the clip body 40 of the clip 4 is preferably formed of a bioabsorbable material. More preferably, a major part (most part) of the clip body 40 is entirely formed integrally of a bioabsorbable material. This ensures that the major part of the clip body 40 is absorbed into a living organism after a predetermined period of time, and is not left in the living organism, so that influences of the clip body 40 on the human body can be eliminated.
  • the thread 46 also is preferably formed of a bioabsorbable material.
  • the bioabsorbable material to be used examples include polylactic acid, polyglycolic acid, and polydioxanone, used singly, and complexes thereof.
  • the material constituting the clip body 40 of the clip 4 is not limited to the bioabsorbable material; for example, a biocompatible material such as a resin and a metal can be used for this purpose.
  • the material constituting the thread 46 is also not limited to the bioabsorbable material.
  • the clip body 40 of the clip As for the physical properties required for the clip body 40 of the clip 4, particularly for the deformation capability of the deformation portion 42, excellent hinge characteristic is desirable. Specifically, a clip body 40 having a tensile strength of 250 to 500 (Kg/cm 2 ), an elongation of 150 to 800%, a tensile modulus of 8 to 20 ( ⁇ 10 3 Kg/cm 2 ) and a bending strength of 300 to 700 (Kg/cm 2 ) is preferred. By fulfilling these physical property values, the clip body 40 possesses excellent hinge characteristics, and the deformation portion 42 can have a desired deformation capability.
  • the deformation portion 42 of the clip 4 is in the form of being elongated in a direction substantially perpendicular to the anchor portion 41 and contracted in a direction substantially parallel to the anchor portion 41 as shown in Fig. 5A .
  • the corner portion 421 of the deformation portion 42 is gradually moved downward in Fig. 5A and the deformation portion 42 is continuously deformed from the form shown in Fig. 5A to the form shown in Fig. 5B , and then to the form shown in Fig. 5C .
  • an in vivo tissue membrane can be clamped between the anchor portion 41 and the deformation portion 42 so as to close up a wound hole.
  • the deformation portion 42 changes from the form shown in Fig. 5A to the form shown in Fig. 5C , the deformation portion 42 is gradually contracted in a direction substantially perpendicular to the anchor portion 41 and is gradually expanded in a direction substantially parallel to the anchor portion 41.
  • the knot 461 is of such a nature that the knot can be moved only in the distal direction as has been described above, the condition where the deformation portion 42 is in a desired form is maintained by the thread 46.
  • the degree of deformation of the deformation portion 42 can be regulated (adjusted) continuously, with the distance between the two corner portions 421, 422 being regulated (adjusted) continuously).
  • the condition can be maintained.
  • This makes it possible to cope with a variety of situations or cases (i.e., to use the invention with a variety of different conditions of in vivo tissue membranes), such as a person with a thick in vivo tissue membrane, a person with a thin in vivo tissue membrane, a person with a hard in vivo tissue membrane, and a person with a soft in vivo tissue membrane.
  • the configuration of the clip is naturally not limited to the particular construction described above and shown in the drawing figures, in as much as it preferably possesses an anchor portion, a deformation portion and a thread (thread-like member).
  • the shape of the deformation portion of the clip is not limited to the generally rectangular configuration shown, and may be other polygons for example, or may be comerless frame-like shapes such as a circular annular shape and an elliptic annular shape.
  • FIG. 1 A procedure for using the tissue closing device to carry out a stanching (staunching) operation is described below.
  • the arrangement device 3 is assembled.
  • the stopper 12 is first mounted to the tube body 71 of the pusher tube 7 in the vicinity of the hub 72e, the pusher tube 7 is inserted into the outer tube 6 from the proximal side of the outer tube 6, and the stopper 12 is located between the hub 72 of the pusher tube 7 and the hub 62 of the outer tube 6.
  • an end portion of the thread 8 is inserted into the pusher tube 7 from the proximal side of the pusher tube 7, and is led out to the exterior via a distal end portion 712 of the pusher tube 7 and a distal end portion of the outer tube 6. Then, the end portion of the thread 8 is passed through the loop 462 of the thread 46 of the clip 4, is inserted into the pusher tube 7 from the distal side of the outer tube 6 and the pusher tube 7, and is led out to the exterior via a proximal end portion 711 of the pusher tube 7.
  • the deformation portion 42 of the clip 4 is flattened to be deformed into the form shown in Fig. 5A , and the deformation portion 42 is inserted (mounted) into the outer tube 6 from the distal side of the outer tube 6.
  • the cap 9 is inserted into the lumen of the proximal end portion 711 of the pusher tube 7, and is mounted there.
  • both end portions of the thread 8 are clamped between the cap 9 and the proximal end portion 711, to be fixed to the proximal end portion 711, and the distal side relative to both end portions of the thread 8 is disposed in the lumen of the pusher tube 7 along the lumen.
  • the assembly of the arrangement device 3 is thus completed. It is to be recognized that the procedure of assembling the arrangement device 3 is naturally not limited to the above-described procedure.
  • a sheath ordinarily left indwelling after a treatment for therapy (PCI) or diagnosis (CAG) performed using a catheter is used as the sheath.
  • a distal end portion of the sheath 5 is inserted in a blood vessel.
  • the arrangement device 3 is gradually inserted into the through-hole 51 of the sheath 5 from the proximal side of the sheath 5, and, as shown in Fig. 6 , the hub 62 of the outer tube 6 and the hub 52 of the sheath 5 are fitted to each other. As a result of this, the distal end portion of the outer tube 6 protrudes beyond the distal end portion of the sheath 5, and the anchor portion 41 of the clip 4 protrudes, to be inserted in the blood vessel.
  • the body portion 2 is slowly moved in the direction out of the wound hole so that the anchor portion 41 anchors the clip 4 at the wound hole and a neighboring portion of the wound hole and covers the inside of the blood vessel wall.
  • the anchor portion 41 is thus positioned.
  • the deformation portion 42 and the fixing portion 43 of the clip 4 are moved to the outside of the blood vessel.
  • the cap 13 is mounted to the outflow port 623 so that the covering of the wound hole and the neighboring portion of the wound hole with the anchor portion can be conducted.
  • the stopper 12 present between the hub 62 of the outer tube 6 and the hub 72 of the pusher tube 7 is removed.
  • the outer tube 6 or the sheath 5 is moved in the direction of pulling it out of the wound hole, and the hub 72 of the pusher tube 7 and the hub 62 of the outer tube 6 are fitted to each other.
  • the deformation portion 42 of the clip 4 retained at a distal end portion of the outer tube 6 is pushed out of the outer tube 6 by the pusher tube 7 to come off, or be pushed out, of the outer tube 6. Subsequently, as shown in Fig. 11 , the cap 9 is detached from the proximal end portion 711 of the pusher tube 7.
  • the deformation portion 42 covers the wound hole and a neighboring portion of the wound hole from the outside of the blood vessel wall.
  • the anchor portion 41 covers the wound hole and a neighboring portion of the wound hole from the inside of the blood vessel wall.
  • the blood vessel wall is thus clamped between the anchor portion 41 and the deformation portion 42, and the wound hole is closed.
  • the condition in which the deformation portion 42 is in the above-mentioned form is maintained by the thread 46.
  • the body portion 2 and the thread 8 are pulled off, and the clip 4 is disposed (left to indwell) in the living organism. That is, the clip 4 is left behind to indwell in the living organism in the position covering or closing off the wound hole.
  • the condition can be maintained by the thread 46.
  • This makes it possible to cope with a variety of conditions of in vivo tissue membranes, and to apply a stanching operation to a wound hole formed in an in vivo tissue membrane such as a blood vessel wall relatively easily and reliably. Namely, it is possible to close or cover the wound hole relatively easily and reliably, and to achieve an effective stanching.
  • the deformation portion 42 can be deformed relatively easily and reliably. Therefore, if a failure in stanching has occurred, the deformation portion 42 is then assuredly spreading in the direction substantially parallel to the anchor portion 41, so that manual astriction can thereafter be conducted. Accordingly, the stanching operation can be carried out quite safely.
  • the thread 8 is formed as a member different from the thread 46, an operation of cutting the thread within the subcutaneous tissues is not required. Therefore the stanching operation is performed relatively easily and swiftly.
  • FIG. 14 A second embodiment of the tissue closing device according to the present invention will now be described below with reference to Fig. 14 .
  • proximal the upper side
  • distal the lower side
  • the clip (tissue closure) 4 differs from the clip 4 in the first embodiment described above, with the remaining features of the second embodiment being generally the same as in the first embodiment.
  • a thread 46 of the clip 4 is hooked on a corner portion 421 of the deformation portion 42 (an end portion of the deformation portion 42 on the opposite side of an anchor portion 41) and on the anchor portion 41.
  • the thread 46 penetrates the corner portion 421 of the deformation portion 42 and the anchor portion 41.
  • the anchor portion 41 of the clip 4 is provided, in the vicinity of its center, with two holes 413, 414 opposite to each other, with the connection portion 44 between the two holes.
  • the holes 413, 414 are through holes.
  • the thread 46 passes through (penetrates) the hole 425 in the corner portion 421 of the deformation portion 42, the hole 426 in the corner portion 422 and the hole 413 in the anchor portion 41, sequentially from the upper side in Fig. 14 , and then passes through the hole 414 in the anchor portion 41, the hole 427 in the corner portion 422, and the hole 428 in the corner portion 421, and forms a knot 461 on the side of the corner portion 421 (on the outside of the deformation portion 42).
  • tissue closing device 1 According to this tissue closing device 1, the same effects as those of the tissue closing device in the first embodiment described above can be obtained.
  • the connecting portion 44 is provided with no hole through which to pass the thread 46, the strength of the connecting portion 44 can be enhanced as compared with the first embodiment.
  • FIG. 15 A third embodiment of the tissue closing device according to the present invention will now be described below with reference to Fig. 15 .
  • proximal the upper side
  • distal the lower side
  • the clip (tissue closure) 4 differs from the clip 4 in the first embodiment described above, with the remaining features of the third embodiment being generally the same as in the first embodiment.
  • the third embodiment includes a plate-like thread hook portion 45 on the inside surface of the corner portion 422 of the deformation portion 42 of the clip 4 (the inside surface of the deformation portion 42 on the side of the anchor portion 41).
  • the thread hook portion 45 is provided with a hole 451 in the vicinity of its center.
  • the hole 451 is a through hole.
  • the anchor portion 41, the deformation portion 42, the connecting portion 44 and the thread hook portion 45 i.e., the entire clip body 40
  • the thread 46 of the clip 4 is hooked on a corner portion 421 of the deformation portion 42 (an end portion of the deformation portion 42 on the opposite side of the anchor portion 41) and the thread hook portion 45.
  • the thread 46 penetrates the corner portion 421 of the deformation portion 42 and the hole 451 in the thread hook portion 45.
  • the thread 46 passes through (penetrates) the hole 425 in the corner portion 421 of the deformation portion 42, and the hole 451 in the thread hook portion 45, sequentially from the upper side in Fig. 15 , and then passes through (penetrates) the hole 428 in the corner portion 421, and forms a knot 461 on the side of the corner portion 421 (on the outside of the deformation portion 42).
  • This tissue closing device 1 using the clip shown in Fig. 15 is capable of achieving the same effects as those of the tissue closing device in the first embodiment described above.
  • FIG. 17(d) also schematically illustrates a pusher tube 7 in broken lines.
  • proximal the upper side
  • distal the lower side
  • the clip (tissue closure) 4 and the pusher tube 7 are respectively different from the clip 4 and the pusher tube 7 in the first embodiment described above, and the other aspects of are generally the same as in the first embodiments.
  • the clip body 40 of the clip 4 is composed of the anchor portion 41, the deformation portion 42, the connecting portion 44 connecting the anchor portion 41 and the deformation portion 42 to each other, and a fixing portion 43 which, in the condition where the deformation portion 42 is in a desired form between a first form and a second form, is engaged with the deformation portion 42 so as to maintain the condition.
  • the anchor portion 41, the deformation portion 42, the connecting portion 44 and the fixing portion 43 are preferably formed integrally of the same material.
  • the deformation portion 42 is provided with a roughly H-shaped slit 424 at its corner portion 421 (an end portion of the deformation portion 42 on the opposite side of the anchor portion 41).
  • the slit 424 is an opening portion which penetrates the frame-like deformation portion 42 and which permits at least a part of the fixing portion 43 to be inserted therein (i.e., to be passed therethrough).
  • the fixing portion 43 has a plate-like (rod-like) shape.
  • the fixing portion 43 is located inside the frame of the deformation portion 42, and its end portion on the lower side in Fig. 16 is linked to the inside surface of a corner portion 422. This ensures that the fixing portion 43 can be swung relative to the anchor portion 41, together with the deformation portion 42.
  • the fixing portion 43 is provided with pawls 431 on one side (right side) in the left-right direction in Fig. 16 .
  • the pawls 431 are preferably plural in number (two, in the example shown) and are positioned side by side at a predetermined spacing from one another along the longitudinal direction of the fixing portion 43 (vertical direction in Fig. 16 ).
  • the fixing portion 43 is also provided with a hole 432 in the vicinity of the center of its end portion on the upper side in Fig. 16 (an end portion of the fixing portion 43 on the opposite side of the anchor portion 41).
  • the hole 432 is a through hole.
  • the thread 46 of the clip 4 is hooked on the corner portion 421 of the deformation portion 42 (the end portion of the deformation portion 42 on the opposite side of the anchor portion 41) and the fixing portion 43 while penetrating the slit 424 in the corner portion 421 of the deformation portion 42 and the hole 432 in the fixing portion 43.
  • the thread 46 passes through (penetrates) the slit 424 in the corner portion 421 of the deformation portion 42 and through the hole 432 in the fixing portion 43, sequentially from the upper side in Fig.
  • the knot 461 is formed to be greater in size than the gap (the dimension in the left-right direction in Fig. 16 ) of the slit 424.
  • the inside diameter of the lumen of the distal end portion 712 of the pusher tube 7 is set to be greater than the inside diameter of the lumen at a location on the proximal side relative to the distal end portion 712.
  • the inside diameter of the lumen of the distal end portion 712 is greater than the fixing portion 43 of the clip 4.
  • the maintaining function of the thread 46 and the maintaining function of the fixing portion 43 are selectively performed according to the degree of deformation of the deformation portion 42 between the first form and the second form.
  • the first form of the deformation portion 42 as a reference, in the region where the degree of deformation of the deformation portion 42 is small, the condition where the deformation portion 42 is in a desired form is maintained by the thread 46.
  • the region where the degree of deformation of the deformation portion 42 is large, the condition where the deformation portion 42 is in a desired form is maintained by the fixing portion 43.
  • the deformation portion 42 is in the form of being stretched in a direction substantially perpendicular to the anchor portion 41 and contracted in a direction substantially parallel to the anchor portion 41, as shown in Fig. 17(a) . Then, as the knot 461 is moved in the distal direction and the thread 46 is tightened, the corner portion 421 of the deformation portion 42 is gradually moved downward in Fig. 17(a) , so that the deformation portion 42 is deformed continuously from the form shown in Fig. 17(a) to the form shown in Fig. 17(b) . In addition, since the knot 461 is such a knot that it can slide toward the distal direction, the condition where the deformation portion 42 is in a desired form is maintained by the thread 46.
  • the corner portion 421 of the deformation portion 42 is pushed downward in Fig. 17(b) by the pusher tube 7.
  • the fixing portion 43 is located inside the lumen of the pusher tube 7, and does not constitute an obstacle as illustrated in Fig. 17(c) .
  • the corner portion 421 of the deformation portion 42 is moved downward, an end portion on the upper side of the fixing portion 43 and the pawl 431 on the upper side of the fixing portion 43 pass through (are inserted into) the slit 424 formed in the corner portion 421, and the pawl 431 is engaged with the corner portion 421.
  • the thread 46 located on the inside of the deformation portion 42 is moved to the outside of the deformation portion 42 via the slit 424, together with the hole 432 in the fixing portion 43.
  • the condition where the deformation portion 42 is in a desired form i.e., the shape of the deformation portion 42
  • the condition where the deformation portion 42 is in a desired form is maintained by the fixing portion 43.
  • the corner portion 421 of the deformation portion 42 is pushed upward in Fig. 17(d)
  • the condition where the deformation portion 42 is in the desired form is maintained by the fixing portion 43.
  • tissue closing device 1 using this clip and pusher tube, the same effects as those of the tissue closing device 1 in the first embodiment described above can be obtained.
  • the deformation portion 42 can be maintained in the desired form by the thread 8.
  • the strength of the connecting portion 44 can be made increased as compared with the first embodiment.
  • the number of pawl(s) provided on the fixing portion of the clip (tissue closure) is not limited to two, but may be one in number or may be three or more.
  • FIG. 18(a)-(b) and 19(a)-(b) schematically illustrate a pusher tube 7 in broken lines.
  • a knot 461 of a thread 46 is shown in the state of not being tied tightly.
  • proximal the upper side
  • distal the lower side
  • the thread (first thread-like member) 46 of the clip (tissue closure) 4 and the thread (second thread-like member) 8 are respectively different from the thread 46 of the clip 4 and the thread 8 in the first embodiment described above.
  • a thread lock member (fixture) 14 is provided. The remaining features associated with this embodiment of the tissue closing device are similar to those associated with the first embodiment of the tissue closing device.
  • the thread (first thread-like member) 46 of the clip 4 is composed of a double thread (double thread-like member) formed by bending back a single thread (thread-like member) so that one end portion constitutes a bent-back portion 463, and the bent-back portion 463 forms a loop 462.
  • a deformation portion 42 is located between the bent-back portion 463 (loop 462) and an anchor portion 41.
  • the thread (second thread-like member) 8 is composed of a double thread (double thread-like member) formed by bending back a single thread (thread-like member) so that one end potion constitutes a bent-back portion 81.
  • a hollow cylindrical stopper 47 is fixed to the other end portion of the thread 8.
  • the stopper 47 may be fixed by, for example, adhesion, caulking or the like.
  • the tissue closure 4 is detachably retained by the thread 8.
  • the stopper 47 inhibits (prevents) an end portion, on the opposite side of the bent-back portion 81, of the thread 8 from entering into the lumen of the pusher tube 7.
  • the thread lock member (fixture) 14 is composed of a filamentous member having a head portion as shown in Fig. 19(a) , and can be elastically deformed into a bent or curved shape, as shown in Figs. 18(a) and 18(b) .
  • the thread lock member 14 may be formed, for example, from a resin material or the like.
  • the bent-back portion 81 of the thread 8 is located at a proximal end portion 711 of the pusher tube 7.
  • the thread lock member 14 is disposed at the proximal end portion 711 of the pusher tube 7 in the state of being bent or curved by being hooked on the bend-back portion 81 of the thread 8.
  • the head portion side and the distal end side of the thread lock member 14 are both positioned in the outside of the pressure tube 7.
  • the stopper 47 is gripped by fingers of a hand, and while pulling the stopper 47 (thread 8) a little so as to apply a tension to a thread 8 (thereby pulling the thread 46 of the clip 4), the pusher tube 7 (body portion 2) is pushed in the direction of inserting it into a wound hole.
  • the bent-back portion 81 of the thread 8 can be inhibited (prevented) from moving in the distal direction inside the lumen of the pusher tube 7, whereby the thread 46 of the clip 4 can be pulled assuredly.
  • tissue closing device 1 According to this tissue closing device 1, the same effects as those of the tissue closing device 1 in the first embodiment described above can be obtained.
  • this tissue closing device 1 since the loop 462 is formed by the bent-back portion 463 of the thread 46, the work of assembling the clip 4 and the operation of pushing the knot 461 by the pusher tube 7 so as to deform the deformation portion 42 can be performed easily and swiftly, as compared with the case where a knot other than the knot 461 is tied in the thread 46 and is used as a loop.
  • the reason is as follows. In the case where a knot other than the knot 461 is formed and is used as a loop, at the time of deforming the deformation portion 42 in a stanching operation, it is necessary to push only the knot 461 without pushing the new knot constituting the loop, which means very severe conditions for the operation.
  • the side of the bent-back portion 81 of the thread 8 may once enter into a living organism.
  • the bent-back portion 81 and the portions near the bent-back portion 81 of the thread 8 can be located in the lumen of the pusher tube 7, so that a sterile condition can be maintained, and the stanching operation can be performed quite safely.
  • the thread 8 can be passed through the loop 462 of the thread 46 more smoothly and the loop 462 of the thread 46 can be moved in the lumen of the pusher tube 7 more smoothly, as compared with the case where a knot other than the knot 461 is formed and is used as a loop.
  • FIG. 20 and 21 A sixth embodiment of the tissue closing device according to the present invention will be described below with reference to Figs. 20 and 21 .
  • the upper side will be referred to as “proximal” and the lower side will be referred to as “distal”.
  • distal the lower side
  • the following detailed description of the sixth embodiment will primarily describe differences associated with the sixth embodiment relative to the first embodiment, and a detailed description of features in the sixth embodiment that are similar to those in the first embodiment will not be repeated.
  • an anchor portion 410 is different from the anchor portion 41 in the first embodiment described above, and the other points are the same as in the first embodiment.
  • the anchor portion 410 is connected to the connection portion 44 on an eccentric position of a flat surface portion 415 of the anchor portion 410.
  • the connection position is to the right side beyond a center position of the flat surface portion 415 as shown in Fig. 20 .
  • the connection portion 44 is connected to the anchor portion 410 at a position offset from a center point of the anchor portion 410.
  • the length of a left-side portion a of the flat surface portion 415 is longer than the length of a right-side portion b of the flat surface portion 415.
  • the total length of the anchor portion 410 is equal to the total length of the anchor portion in the first embodiment.
  • the longer portion a of the anchor portion 41 is arranged upstream of blood flow (a side of a heart) and the shorter portion b of the anchor portion 41 is arranged downstream of blood flow (a side of a peripheral) when the anchor portion 41 is positioned in a blood vessel.
  • the closing device 1 when the closing device 1 is drawn out, the resistance of the blood vessel wall increases and it is difficult for the anchor portion 410 to escape. Because the closing device 1 which is being drawn out generates the strongest resistance on a portion that is the acute angle side of the anchor portion 41 with the blood vessel and the closing device 1 (i.e., the right side in Fig. 21 ), the effect of the resistance can be distributed by changing the balance of the anchor (i.e., by positioning the longer portion b of the anchor to the obtuse angle side of the anchor portion 41).
  • the present invention may be embodied in a combination of two or more configurations (characteristic features) of the above-described embodiments.
  • the deformation portion 42 has a frame-like shape which can be deformed between the first form of being elongated in a directions substantially perpendicular to the anchor portion 41 and contracted in a direction substantially parallel to the anchor portion 41 and the second form of being contracted in a direction substantially perpendicular to the anchor portion 41 and expanded in a direction substantially parallel to the anchor portion 41.
  • the deformation portion is not limited to this configuration, and may have any configuration inasmuch as it can be deformed into a form (first form) of being elongated in a direction substantially perpendicular to an anchor portion and a form (second form) of being compressed from this form (first form) toward the anchor portion.
  • the deformation portion can be composed, for example, of a spongy porous member (porous material) containing a resin material (synthetic resin material) as a main material, or the like.

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Claims (28)

  1. Gewebeverschluss zum Verschließen einer Öffnung in einer Wand eines Hohlraums eines lebenden Körpers, mit:
    einem plattenförmigen Verankerungsabschnitt (41), der geeignet ist, von einer Seite der Wand des Hohlraums des lebenden Körpers aus an der Öffnung und um die Öffnung herum gehalten zu werden;
    einem Verformungsabschnitt (42) mit einem rahmenförmigen Körper, wobei der Verformungsabschnitt (42) verformbar ist zwischen einer ersten Form, in der der Körper in einer zu dem Verankerungsabschnitt (41) im Wesentlichen senkrechten Richtung gestreckt ist und in einer zu dem Verankerungsabschnitt (41) im Wesentlichen parallelen Richtung kontrahiert ist, und einer zweiten Form, in der der Körper in einer zu dem Verankerungsabschnitt (41) im Wesentlichen senkrechten Richtung kontrahiert ist und in einer zu dem Verankerungsabschnitt (41) im Wesentlichen parallelen Richtung gestreckt ist; und
    einem fadenartigen Element (46) mit einem Knoten (461), der auf dem fadenartigen Element (46) verschieblich ist, wobei der Knoten (461) in der Lage ist, den Verformungsabschnitt in einer gewünschten Form zwischen der ersten Form und der zweiten Form zu halten.
  2. Gewebeverschluss nach Anspruch 1, wobei der rahmenförmige Körper des Verformungsabschnitts (42) eine Form wie ein Pantograph besitzt.
  3. Gewebeverschluss nach Anspruch 1, wobei der rahmenförmige Körper des Verformungsabschnitts (42) eine polygonale ringförmige Gestalt besitzt, die durch ein starres bandartiges Element mit mehreren biegbaren Abschnitten gebildet wird.
  4. Gewebeverschluss nach Anspruch 1, wobei der rahmenförmige Körper des Verformungsabschnitts (42) eine viereckige Gestalt besitzt, die durch vier integrierte Verbindungsglieder gebildet wird, und so verformbar ist, dass sich zwei Eckabschnitte in diagonal entgegengesetzten Positionen aufeinander zu und voneinander weg bewegen, wenn sich der Verformungsabschnitt zwischen der ersten und der zweiten Form verformt.
  5. Gewebeverschluss nach Anspruch 1, wobei sich der Knoten (461) dann, wenn das fadenartige Element (46) den Verformungsabschnitt (42) in der gewünschten Form hält, an einem ersten Endabschnitt auf einer dem Verankerungsabschnitt (41) gegenüberliegenden Seite des Verformungsabschnitts (42) befindet.
  6. Gewebeverschluss nach Anspruch 1, wobei das fadenartige Element (46) an einem Endabschnitt des Verformungsabschnitts (42) auf einer dem Verankerungsabschnitt (41) gegenüberliegenden Seite eingehakt ist und an einem anderen Endabschnitt des Verformungsabschnitts auf einer näher bei dem Verankerungsabschnitt (41) liegenden Seite eingehakt ist.
  7. Gewebeverschluss nach Anspruch 1, wobei der Verankerungsabschnitt (41) und der Verformungsabschnitt (42) in einem Stück aus demselben Material einstückig ausgebildet sind.
  8. Gewebeverschluss nach Anspruch 1, der ferner einen Verbindungsabschnitt (44) umfasst, der den Verankerungsabschnitt (41) und den Verformungsabschnitt (42) miteinander verbindet.
  9. Gewebeverschluss nach Anspruch 8, wobei der Verankerungsabschnitt (41), der Verbindungsabschnitt (44) und der Verformungsabschnitt (42) in einem Stück aus demselben Material einstückig ausgebildet sind.
  10. Gewebeverschluss nach Anspruch 8, wobei das fadenartige Element (46) an einem Endabschnitt des Verformungsabschnitts (42) auf einer dem Verankerungsabschnitt (41) und dem Verbindungsabschnitt (44) gegenüberliegenden Seite eingehakt ist, wobei das fadenartige Element (46) den Verformungsabschnitt (42) und den Verbindungsabschnitt (44) durchdringt.
  11. Gewebeverschluss nach Anspruch 1, wobei das fadenartige Element (46) an einem Endabschnitt des Verformungsabschnitts (42) auf einer dem Verankerungsabschnitt (41) gegenüberliegenden Seite eingehakt ist, wobei das fadenartige Element (46) den Verformungsabschnitt (42) und den Verankerungsabschnitt (41) durchdringt.
  12. Gewebeverschluss nach Anspruch 1, der ferner einen Einfädelhakenabschnitt (45) umfasst, der ein Loch (451) besitzt, wobei der Einfädelhakenabschnitt (45) auf einer Innenseite des Verformungsabschnitts (41) vorgesehen ist und das fadenartige Element (46) an einem ersten Endabschnitt des Verformungsabschnitts (42) auf einer dem Verankerungsabschnitt (41) gegenüberliegenden Seite eingehakt wird, indem es ein Loch (425, 428) in dem Verformungsabschnitt (42) durchdringt, wobei das fadenartige Element (46) an dem Einfädelhakenabschnitt (45) eingehakt wird, indem es das Loch (451) des Einfädelhakenabschnitts (45) durchdringt.
  13. Gewebeverschluss nach Anspruch 12, wobei der Verformungsabschnitt (42) und der Einfädelhakenabschnitt (45) in einem Stück aus demselben Material einstückig ausgebildet sind.
  14. Gewebeverschluss nach Anspruch 1, mit einem von dem fadenartigen Element (46) verschiedenen Befestigungsabschnitt (43), wobei der Befestigungsabschnitt (43) in dem Verformungsabschnitt (42) vorgesehen ist und wobei der Befestigungsabschnitt (43) an dem Verformungsabschnitt (42) angreift, wenn sich der Verformungsabschnitt (42) in der gewünschten Form zwischen der ersten Form und der zweiten Form befindet, um den Verformungsabschnitt in der gewünschten Form zu halten.
  15. Gewebeverschluss nach Anspruch 14, wobei der Befestigungsabschnitt (43) auf einer Seite des Verankerungsabschnitts (41) an der Innenseite des Verformungsabschnitts (42) befestigt ist.
  16. Gewebeverschluss nach Anspruch 14, wobei der Verformungsabschnitt (42) und der Befestigungsabschnitt (43) in einem Stück aus demselben Material einstückig ausgebildet sind.
  17. Gewebeverschluss nach Anspruch 14, wobei das fadenartige Element (46) und der Befestigungsabschnitt (43) den Verformungsabschnitt (42) nach dem Grad der Verformung des Verformungsabschnitts (42) zwischen der ersten Form und der zweiten Form wahlweise in der gewünschten Form halten.
  18. Gewebeverschluss nach Anspruch 14, wobei der Verformungsabschnitt (42) einen Öffnungsabschnitt (424) umfasst, in den wenigstens ein Teil des Befestigungsabschnitts (43) eingesetzt werden kann, und der Befestigungsabschnitt (43) wenigstens eine Klinke (431) umfasst, die geeignet ist, an dem Verformungsabschnitt (42) anzugreifen, wenn der Befestigungsabschnitt (43) in den Öffnungsabschnitt (424) eingesetzt wird.
  19. Gewebeverschluss nach Anspruch 14, wobei der Befestigungsabschnitt (43) ein Loch besitzt und das fadenartige Element (46) an einem ersten Endabschnitt des Verformungsabschnitts (42) auf einer dem Verankerungsabschnitt (41) und dem Befestigungsabschnitt (43) gegenüberliegenden Seite eingehakt ist, wobei das fadenartige Element (46) den ersten Endabschnitt und das Loch des Befestigungsabschnitts (43) durchdringt.
  20. Gewebeverschluss nach Anspruch 14, wobei:
    ein erster Endabschnitt des Verformungsabschnitts (42) auf einer dem Verankerungsabschnitt (41) gegenüberliegenden Seite mit einem Öffnungsabschnitt (424) versehen ist, der so gestaltet ist, dass er wenigstens einen Teil des Befestigungsabschnitts (43) aufnimmt;
    der Befestigungsabschnitt (43) mit einem Loch und mindestens einer Klinke (431) versehen ist, die geeignet ist, an dem Verformungsabschnitt (42) anzugreifen, wenn der Befestigungsabschnitt (43) in den Öffnungsabschnitt (424) eingesetzt ist; und
    wenn der Befestigungsabschnitt (43) nicht in den Öffnungsabschnitt (424) eingesetzt ist, durchdringt das fadenartige Element (46) den Öffnungsabschnitt (424) des Verformungsabschnitts (42) und wird an dem Befestigungsabschnitt (43) eingehakt, indem es das Loch des Befestigungsabschnitts (43) durchdringt.
  21. Gewebeverschluss nach Anspruch 20, wobei sich das fadenartige Element (46) dann, wenn der Befestigungsabschnitt (43) in den Öffnungsabschnitt (44) eingesetzt ist und die Klinke (431) mit dem Verformungsabschnitt (42) in Eingriff steht, zusammen mit dem Loch des Befestigungsabschnitts (43) außerhalb des Verformungsabschnitts (42) befindet.
  22. Gewebeverschluss nach Anspruch 1, wobei mindestens einer von dem Verankerungsabschnitt (41), dem Verformungsabschnitt (42) und dem fadenartigen Element (46) aus einem biologisch absorbierbaren Material besteht.
  23. Gewebeverschluss nach Anspruch 1, wobei das fadenartige Element (46) aus einem Doppelfaden besteht, dessen einer Endabschnitt als zurückgebogener Abschnitt vorliegt, und so angeordnet ist, dass sich der Verformungsabschnitt (42) zwischen dem zurückgebogenen Abschnitt und dem Verankerungsabschnitt (41) befindet, wobei der zurückgebogene Abschnitt eine Schlaufe bildet.
  24. Gewebeverschluss nach Anspruch 1, wobei die Wand des Hohlraums des lebenden Körpers eine Wand eines Blutgefäßes ist und die eine Seite der Wand des Hohlraums des lebenden Körpers eine Innenseite der Wand eines Blutgefäßes ist.
  25. Gewebeverschließende Vorrichtung, mit:
    einem Gewebeverschluss (4) nach einem der Ansprüche 1 bis 24;
    einer Anordnungsvorrichtung (3), die eine langgestreckte Form besitzt, wobei die Anordnungsvorrichtung den Gewebeverschluss (4) lösbar an einem distalen Endabschnitt desselben festhält; und die geeignet ist, eine Gewebemembran einer Wand eines Hohlraums eines lebenden Körpers mit dem Gewebeverschluss (4) zu durchdringen.
  26. Gewebeverschließende Vorrichtung nach Anspruch 25, wobei der Gewebeverschluss (4) ein erstes Fadenelement (46) umfasst, das aus einer Schlaufe (462) besteht, und ferner ein zweites Fadenelement (8) umfasst, das durch die durch den zurückgebogenen Abschnitt des ersten Fadenelements (46) gebildete Schlaufe verläuft, wobei der Gewebeverschluss (4) von dem zweiten Fadenelement (8) lösbar festgehalten wird.
  27. Gewebeverschließende Vorrichtung nach Anspruch 26, wobei das zweite Fadenelement (8) aus einem Doppelfaden besteht, der einen Endabschnitt besitzt, bei dem es sich um einen zurückgebogenen Abschnitt handelt.
  28. Gewebeverschließende Vorrichtung nach Anspruch 27, wobei die Anordnungsvorrichtung (3) ein Lumen besitzt, das sich entlang einer Längserstreckung der Anordnungsvorrichtung erstreckt, um das zweite Fadenelement (8) hindurchzuführen, und wobei sich der zurückgebogene Abschnitt des zweiten Fadenelements an einem proximalen Endabschnitt der Anordnungsvorrichtung befindet, und ferner mit einem Befestigungsmittel (47), um zu unterbinden, dass sich der zurückgebogene Abschnitt des zweiten Fadenelements in dem Lumen der Anordnungsvorrichtung in einer distalen Richtung bewegt.
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US20060135991A1 (en) 2006-06-22
US7875052B2 (en) 2011-01-25

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